Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years.

Penetrating Abdominal Trauma Clinical Trial

— PAT-HMAR  

Official title:

Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years. Do we Need to Change the Protocol?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06228261
• Other study ID #: Penetrating abdotrauma HMAR
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: January 2024
• Source: Hospital del Mar
• Contact: Ana María González Castillo, PhD
• Phone: +34665126866
• Email: amgonzalezcastillo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Penetrating abdominal trauma (PAT) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. Last guidelines published in 2014 recommend the use of FAST and CXR as the Gold Standard method for evaluating. Computed Tomography (CT) is widely used in stable patients with PAT and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. This study aims to assess the management of PAT in our institution and with its results review the actual protocol.

Description:

Penetrating abdominal trauma (PAT) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. Last guidelines published in 2014 recommend the use of FAST and CXR as the Gold Standard method for evaluating. Computed Tomography (CT) is widely used in stable patients with PAT and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. This study aims to assess the management of PAT in our institution and with its results review the actual protocol.

A retrospective unicentric study will be conducted on a prospective database of stab wounds at the Department of General Surgery of Hospital del Mar over a 15-year period. The normality of the distribution of quantitative variables will be assessed using the Kolmogorov-Smirnov test. Comparison between qualitative variable groups will be performed using the Chi-square test or Fisher's exact test when appropriate, and non-parametric tests like the Mann-Whitney U test will be used to evaluate the significance of differences in means of quantitative variables. The odds ratios (OR) of predictor variables with outcome variables will be determined.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All penetrating trauma patients admitted in the emergency department.

Exclusion Criteria:

• All patients with any other diagnostic different from penetrating trauma

• Blunt trauma patients admitted in the emergency department

Related Conditions & MeSH terms

• Abdominal Injuries
• Penetrating Abdominal Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	The main outcome measure was the total of complications in patients with a penetrating abdominal trauma assessed by the Clavien-Dindo Classification.	2008-2023
Primary	Mortality	The second main outcome measure was the total of deaths in patients with a penetrating abdominal trauma assessed by preventable or non-preventable deaths.	2008-2023
Secondary	Explorations	To describe the explorations that has been ordered: eFAST, CT Scan, explorative laparoscopy or laparotomy.	2008-2023
Secondary	Demographyc description	Description of the age and gender (Male / Female)	2008-2023
Secondary	Physiologic description	Description of the vitals at arrival (bates per minute, blood pressure)	2008-2023
Secondary	Wound and abdominal exploration	Description of the wound: bleeding, longitude, number of wounds and the abdominal explorations: peritonism or no peritonism.	2008-2023